Neuron-Spectrum

GUDID 04650075330098

The digital systems Neuron-Spectrum-1 are intended for use as digital neurophysiological systems intended for recording, processing and display biopo

NEUROSOFT, OOO

Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph

• Primary Device ID: 04650075330098
• NIH Device Record Key: ceb250ce-0bfa-42ce-8554-99455e4c09cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuron-Spectrum
• Version Model Number: Neuron-Spectrum-1
• Company DUNS: 643212926
• Company Name: NEUROSOFT, OOO
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04650075330098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133995

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Neuron-Spectrum]

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• 04650075330128: The digital systems Neuron-Spectrum-4 are intended for use as digital neurophysiological system
• 04650075330111: The digital systems Neuron-Spectrum-3 are intended for use as digital neurophysiological system
• 04650075330104: The digital systems Neuron-Spectrum-2 are intended for use as digital neurophysiological system
• 04650075330098: The digital systems Neuron-Spectrum-1 are intended for use as digital neurophysiological system
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